Aerobic Exercise for Alzheimer's Disease

(BIMII Trial)

Overseen By Marc J Poulin, PhD, DPhil

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Dementia, Stroke, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 6 months

264 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether regular aerobic exercise can help prevent dementia in older adults with memory issues. The exercise program aims to improve brain health by boosting blood flow and fitness. Researchers hope to show that this can slow down or prevent cognitive decline.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is aerobic exercise safe for people with Alzheimer's disease?

Studies suggest that older adults with Alzheimer's disease can safely participate in aerobic exercise programs. However, the response to exercise may vary, and some individuals may experience different levels of improvement in fitness. ^{1 2 3 4 5}

How does aerobic exercise treatment differ from other treatments for Alzheimer's disease?

Aerobic exercise is unique because it may improve cognitive function and modify the underlying disease process in Alzheimer's patients, unlike many standard treatments that primarily focus on symptom management. It involves physical activity, such as cycling, which can enhance cardiorespiratory fitness and quality of life, offering a non-drug approach to managing the condition. ^{1 3 4 5 6}

What data supports the effectiveness of the treatment Aerobic Exercise for Alzheimer's Disease?

Research suggests that aerobic exercise might help improve memory, thinking skills, and physical abilities in people with Alzheimer's disease. Some studies show that older adults with Alzheimer's can participate in aerobic exercise and experience improvements in dementia symptoms, although results can vary. ^{1 2 5 7 8}

Who Is on the Research Team?

Marc J Poulin, PhD, DPhil

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for inactive adults aged 50-80 with memory complaints but no dementia, and at least one vascular risk factor like high blood pressure or diabetes. They should not be doing vigorous exercise more than twice a week and must speak English fluently. People with serious illnesses, history of stroke, or other conditions that could affect the study can't join.

Inclusion Criteria

I am between 50-80 years old, feel I have memory issues, but don't have dementia, and have risk factors for Alzheimer's or related diseases.

I have a history of high blood pressure, diabetes, obesity (BMI <40), high cholesterol, smoking, or past heart disease without recent symptoms.

Subjective cognitive symptoms self-reported using the MAC-Q Memory Complaint Questionnaire with a score of ≥25

Exclusion Criteria

History of dementia

I am not fluent in English.

Contraindication for the intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-month aerobic exercise intervention, including supervised sessions 3 days/week with progressive intensity and duration.

6 months

3 visits per week (in-person)

Follow-up

Participants are monitored for changes in cognition, cerebral blood flow, and cerebrovascular reserve, with assessments at 12 and 18 months post-intervention.

12 months

Assessments at 12 and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic exercise
• Stretch and Strength

Trial Overview The trial tests if regular aerobic exercise can prevent or slow down cognitive decline in older adults at risk of Alzheimer's Disease and related dementias (ADRD). Participants will do either aerobic exercises or stretching-toning exercises to see which helps brain health and cognition more.

How Is the Trial Designed?

Group I: Stretch and Strength Experimental Treatment 1 Intervention

A control group will meet on a similar schedule as the exercise group for sessions on stretching and toning but without aerobic exercise. Based on prior RCTs of similar interventions the investigators expect this control to be ineffective or minimally effective, but anticipate that it will increase participant enthusiasm and retention. All assessments will be conducted in this arm.

Group II: Aerobic exercise Experimental Treatment 1 Intervention

Participants will take part in a supervised 6-month-long aerobic (walk/jog) training program held 3 days/week. Each session will include a 5-min warm-up, 20-40 min of aerobic exercise (walking, jogging), 5-min cool-down, and stretching. Exercise prescriptions will follow current principles and guidelines established by ACSM/AHA, including sufficient warm-up, cool-down, and ongoing provision of safety precautions/exercise tips. As participants progress, the duration of aerobic exercise will increase from 20 (month 1) to 30 (months 2-3) and 40 min (months 4-6), with proportional increases to warm-up and cool-down periods. Exercise intensity will be based on individual maximal oxygen uptake (VO2 max), measured at baseline. Intensity will build from 30-45% (months 1-3) to mitigate the risk of injury and will progress to 60-70% (months 4-6) heart rate reserve (HRR).

Aerobic exercise is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function
• Reduction of depression

Approved in European Union as Aerobic Exercise for:

• Cardiovascular rehabilitation
• Improvement of physical function
• Enhancement of cognitive function

Approved in Canada as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

A 2-month aerobic training program showed that older men with moderate Alzheimer's disease (AD) can improve their cardiorespiratory fitness, while those with severe AD may not benefit as much, indicating variability in response to exercise.

The study suggests that a longer duration of aerobic training, such as 6 months, may be more effective for improving fitness in older adults with AD, highlighting the need for tailored exercise programs based on individual fitness levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic training for older men with Alzheimer's disease: individual examples of progression. Yu, F., Leon, AS., Bliss, D., et al.[2021]

A 26-week supervised aerobic exercise program improved functional ability in individuals with early Alzheimer's disease, as evidenced by a significant gain in scores on the Disability Assessment for Dementia.

Increased cardiorespiratory fitness from the exercise was linked to better memory performance and less hippocampal atrophy, indicating that improving physical fitness may help support brain health in early Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial. Morris, JK., Vidoni, ED., Johnson, DK., et al.[2023]

Aerobic exercise training may improve physical fitness, performance, daily living activities, cognition, and psychological symptoms in older adults with Alzheimer's disease, based on a review of 12 studies.

The Functional Impact of aerobic exercise Training in Alzheimer's disease (FIT-AD) model was developed to guide future research and practice, emphasizing the interconnected benefits of aerobic exercise for individuals with Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guiding research and practice: a conceptual model for aerobic exercise training in Alzheimer's disease. Fang Yu, .[2021]

A 6-month moderate intensity cycling program improved cardiorespiratory fitness in 8 participants with Alzheimer's disease, as indicated by a significant reduction in heart rate during exercise tests.

However, the study did not find significant changes in lower extremity function or overall physical performance, suggesting that while aerobic exercise can enhance fitness, its effects on physical functioning may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintaining physical fitness and function in Alzheimer's disease: a pilot study. Yu, F., Savik, K., Wyman, JF., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Aerobic training for older men with Alzheimer's disease: individual examples of progression. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Facilitating aerobic exercise training in older adults with Alzheimer's disease. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise on physical performance in patients with Alzheimer's disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Guiding research and practice: a conceptual model for aerobic exercise training in Alzheimer's disease. [2021]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The Effects of Aerobic Exercise on Cognitive Function of Alzheimer's Disease Patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Maintaining physical fitness and function in Alzheimer's disease: a pilot study. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Acute Exercise and Cognitive Function in Alzheimer's Disease. [2021]